MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER SEPTAL OCCLUDER; CARDIAC OCCLUSION DEVICE

Model Number 9-ASD-010

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 01/17/2014

Event Type  Injury  

Event Description

A 25mm numed sizing balloon was used to cross the defect.By tee this balloon seemed to be in one of the smaller, more inferior defects.The guidewire was then pulled back to the right atrium and the septum was recrossed across the retroaortic, larger defect.The balloon was inflated again and the defect measured 9mm.A 10mm amplatzer septal occluder (aso) was selected and a 6f amplatzer torqvue 45 delivery system (dtv45) was placed over the guidewire into the left upper pulmonary vein.The aso was deployed and released.Echo showed a large residual defect near the coronary sinus, and the additional small posterior defect was still patent.The aso was snared with a 10mm gooseneck snare and pulled into a 10f sheath.A 25mm amplatzer cribriform occluder (aco) was then selected.The aco was deployed, and while the posterior defect was now covered, the inferior defect near the coronary sinus was still present.The aco was snared and removed.The patient will be referred to surgery for atrial septal defect closure.Please reference mdr# 2135147-2014-00010 for the 25mm aco.

Manufacturer Narrative

The 10mm aso was received at sjm and decontaminated.The aso was grossly and microscopically examined and no anomalies were found.The aso met dimensional specifications when measured with a calibrated caliper.The aso was loaded into a test 7f loader and deployed and retracted without difficulty or deformation, under non-physiological conditions.The device history record for this product was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with sjm specifications and procedures.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: CARDIAC OCCLUSION DEVICE
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 3620446
• MDR Text Key: 4135171
• Report Number: 2135147-2014-00009
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: 9-ASD-010
• Device Catalogue Number: 9-ASD-010
• Device Lot Number: 4082401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/21/2014
• Initial Date FDA Received: 02/10/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 25MM ACO; 25MM NUMED SIZING BALLOON; 10MM GOOSENECK SNARE; 10F DTV
• Patient Outcome(s): Required Intervention
• Patient Age: 3 YR
• Patient Weight: 14